Cough Cold and Sore Throat

Description

This formulation contains Acetaminophen 325 mg, a pain reliever and fever reducer; Dextromethorphan HBr 10 mg, a cough suppressant; Guaifenesin 200 mg, an expectorant; and Phenylephrine HCl 5 mg, a nasal decongestant. The product is designed for children aged 6 to 11 years and is presented in a berry flavor. It provides relief from cough, sore throat, stuffy nose, and chest congestion, while also aiding in the breakdown of mucus. The product is tamper evident; do not use if the carton is opened or if the printed safety seal around the bottle or under the cap is broken or missing. Distributed by Walgreen Co., located at 200 Wilmot Rd., Deerfield, IL 60015. For more information, visit walgreens.com.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms in pediatric patients. Specifically, it alleviates cough due to minor throat and bronchial irritation, reduces the intensity and impulse to cough, and assists in promoting sleep. Additionally, it addresses nasal congestion, stuffy nose, sore throat, minor aches and pains, and headache.

This medication also temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is intended for use in children aged 6 years and older. The recommended dosage for children aged 6 to under 12 years is 10 mL, administered using the enclosed dosing cup specifically designed for this product. It is imperative that healthcare professionals instruct caregivers to utilize only the provided dosing cup and to refrain from using any other dosing devices.

Dosing should not exceed 5 doses within a 24-hour period. If symptoms persist, doses may be repeated every 4 hours as needed, but the total duration of administration should not exceed 5 days unless directed by a physician.

For children under 6 years of age, this product is not recommended for use. Caregivers should be advised to adhere strictly to the dosing guidelines and to avoid exceeding the recommended dosage to prevent the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• In children who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past two weeks. MAOIs are used for the treatment of depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty about the child's prescription, a healthcare professional should be consulted.

• In individuals with a known allergy to acetaminophen or any of the inactive ingredients contained in this product.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use, as outlined in the overdose warning.

Warnings and Precautions

Severe liver damage may occur in pediatric patients taking this product, which contains acetaminophen, if they exceed the maximum daily dosage of 5 doses within a 24-hour period or if they are concurrently using other medications that also contain acetaminophen. Healthcare professionals should monitor patients closely for adherence to dosing guidelines to prevent potential hepatotoxicity.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance without delay.

In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by fever, headache, rash, nausea, or vomiting, healthcare providers should be consulted promptly to rule out serious underlying conditions.

Patients should be advised to stop use and consult a physician if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than 5 days, or if there is any redness or swelling, new symptoms arise, or if fever worsens or persists beyond 3 days, medical evaluation is warranted. A return of cough, particularly if accompanied by a rash or headache that lasts, should also prompt immediate medical consultation, as these may indicate a serious condition.

In the event of an overdose, it is critical to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is essential, even if the patient does not exhibit any signs or symptoms of overdose.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients may experience severe liver damage if they exceed five doses within a 24-hour period, which is the maximum daily amount, or if they take this product concurrently with other medications containing acetaminophen. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical attention is crucial, even if no symptoms are initially apparent. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay.

Allergic reactions may also occur, with severe skin reactions being a notable risk. Symptoms of such reactions can include skin reddening, blisters, and rash. Should any of these symptoms arise, patients must discontinue use and seek medical assistance immediately.

Patients should be vigilant for signs of serious conditions, particularly if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. In these cases, consulting a healthcare provider promptly is recommended.

Common adverse reactions that warrant discontinuation of use and consultation with a doctor include nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts longer than five days, or if redness or swelling is observed, medical advice should be sought. Patients should also be alert to the development of new symptoms or if fever worsens or persists beyond three days. A cough that recurs or occurs alongside a rash or headache that lasts should also prompt a consultation with a healthcare professional.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, the use of this medication is contraindicated in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within two weeks following the discontinuation of an MAOI. The interaction may lead to serious adverse effects, including hypertensive crises.

Additionally, caution is advised when this medication is used in children who are concurrently taking warfarin, a blood-thinning agent. It is recommended that a healthcare professional, such as a doctor or pharmacist, be consulted prior to use to assess the potential for increased bleeding risk and to determine if any dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Cough Cold and Sore Throat (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 10 mL using the dosing cup provided. The use of this medication is not recommended for children under 6 years of age.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of polypharmacy and the increased likelihood of comorbidities in geriatric patients, which may necessitate dosage adjustments or heightened vigilance in monitoring treatment outcomes.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use, as there may be potential risks to the fetus; however, specific studies or data regarding these risks are not provided in the prescribing information.

No specific dosage modifications for pregnant individuals are mentioned; therefore, it is essential for healthcare professionals to provide guidance tailored to the individual patient's circumstances. This product should only be used if clearly needed and after a thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored due to the potential for severe liver damage associated with this product, which contains acetaminophen. It is critical that patients do not exceed five doses within a 24-hour period, as this represents the maximum daily amount. Additionally, patients should avoid concomitant use with other medications containing acetaminophen to mitigate the risk of liver injury.

Before administration, it is advisable for caregivers to consult a healthcare professional if the patient has a history of liver disease. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential, even if the patient does not exhibit any signs or symptoms of overdose.

Overdosage

In cases of overdose, the administration of doses exceeding the recommended amount may lead to significant liver damage. It is imperative that healthcare professionals remain vigilant regarding the potential for serious adverse effects associated with overdosage.

Immediate medical assistance is crucial in the event of an overdose. Healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay. Prompt intervention is essential, even in the absence of noticeable signs or symptoms, as early treatment can mitigate the risk of severe complications.

Monitoring and management of the patient should be initiated as soon as possible, with a focus on assessing liver function and implementing appropriate therapeutic measures.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of adhering to the recommended dosage, as taking more than the directed amount may lead to liver damage. In the event of an overdose, it is crucial for patients to seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222, as prompt medical attention is essential even if no signs or symptoms are present.

Providers should emphasize that patients must not exceed the recommended dose and should refer to the overdose warning for further details.

Additionally, healthcare providers should encourage patients to consult with a doctor before use if their child has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough that produces excessive phlegm, a breathing problem such as chronic bronchitis, or a persistent or chronic cough, such as that associated with asthma.

Furthermore, it is important for patients to discuss with their healthcare provider or pharmacist if their child is currently taking the blood-thinning medication warfarin, as this may require special consideration.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper handling and storage conditions must be adhered to in order to maintain product efficacy and safety.

Additional Clinical Information

Patients should be informed that the medication is administered orally. It is crucial to keep the product out of reach of children. Clinicians should advise patients to consult a doctor before use if the patient has any of the following conditions: liver disease, heart disease, high blood pressure, diabetes, thyroid disease, a cough with excessive phlegm, or chronic breathing problems such as bronchitis or asthma. Additionally, patients taking the blood-thinning medication warfarin should seek guidance from a healthcare professional prior to use.

Patients must adhere to the recommended dosage and should not exceed the directed amount. They should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond five days; if redness or swelling occurs; if new symptoms arise; if fever worsens or lasts more than three days; or if a cough returns with a rash or headache that lasts. These symptoms may indicate a serious condition.

Drug Information (PDF)

This file contains official product information for Cough Cold and Sore Throat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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